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FDA 510(k)

BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE

K-Number: K801659 · 1980-09-09

ApplicantCoburn Optical Ind., Inc.
Decision Date1980-09-09
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Coburn Optical Ind., Inc.. It received FDA 510(k) clearance on 1980-09-09 under 510(k) number K801659. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE?

BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Coburn Optical Ind., Inc.. The 510(k) number is K801659.

When did BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE receive FDA 510(k) clearance?

BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801659.

Who is the listed applicant for BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE?

The FDA 510(k) record lists Coburn Optical Ind., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE?

The FDA product code for BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE is HJO.

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Other records listing Coburn Optical Ind., Inc. as applicant

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K892348MAGNILINK SYSTEM 201K892347MAGNILINK SYSTEM 101K892350MAGNILINK SYSTEM 402/5K892349MAGNILINK SYSTEM 209K892351MAGNILINK SYSTEM 602K862188IRRIGATION & ASPIRATION/VITRECTOMY DEVICE

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Related Devices (Code: HJO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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